MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POROUS SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	71356012
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left thr surgery performed on (b)(6) 2008 due to a post traumatic arthritis and severe pain, the patient started experiencing pain in his left hip.On (b)(6) 2021 a blood test was performed and levels of chromium and cobalt were at 1.0 ng/ml and 3.3 ng/ml, respectively.A bone scan was performed on (b)(6) 2021 that shows focally increased delayed activity at the distal margin of the left femoral stem possibly from early loosing.The patient's condition is ongoing, reporting a constant 2 on the pain scale, and up to 7.Patient is seeking for help.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per bone scan on (b)(6) 2021, ¿mildly increased activity about the collar of the femoral component on delayed images corresponds to areas of heterotopic ossification.Focal increased delayed activity at distal margin of left femoral stem possibly from early loosening.Repeat radiography might be considered for identification of early osteolysis about the femoral stem.¿ in addition, the clinical root cause of the reported pain cannot be definitively concluded.However, the patients¿ history of traumatic injury that result in acetabular and femoral deformity, traumatic arthritis, heterotopic ossification and/or possible early loosening may be contributing factors to his reported pain.A mal performance of the implant cannot be concluded.The patient impact is determined to be the reported pain.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed in adverse events in primary and revision surgery that failure to observe the warnings and precautions, trauma, strenuous activity, implant alignment, patient non-compliance, involuntary muscular disorders, improper or duration of service increase the risk of loosening of implant components, which may lead to revision surgery.Additionally, revealed in warnings and precautions that the correct selection of the neck length and cup, and stem positioning, are important.Muscle looseness and/or malpositioning of components may result in loosening of components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, loss of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY SO POROUS SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19773202
• Report Number: 1020279-2024-01405
• Device Sequence Number: 12789849
• Product Code: MRA
• UDI-Device Identifier: 03596010567826
• UDI-Public: 03596010567826
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2017
• Device Catalogue Number: 71356012
• Device Lot Number: 07HM07846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74120164/71256/ACETLR CUP HAP 64MM W/ IMPTR; 74122558/9820/HEMI HEAD 58MM; 74222400/10075/MODULAR SLEEVE +8MM 12/14
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male